The Extent of the Harmonising Effect

Much attention has been given here to the importance of which legal basis is used for legal acts and the implications of that choice for the harmonising effect of such acts. However, it must be recognised that the notion of harmonisation is more complex than just a matter of choice between legal bases entailing either complete harmonisation or minimum harmonisation. As noted above, market-related legal acts can allow for more protective national measures and environmental acts can include elements of complete harmonisation. In the end it is often the substantive contents of a legal act more than anything else that determine the level of harmonisation which it affects.

That a certain activity or product is subject to harmonising EU legislation does not mean that all measures that a Member State may want to take in relation to such an activity or such product have been harmonised. An illustrative example is provided by the Toolex Alpha case in which the Court of Justice assessed a Swedish prohibition of a certain chemical substance (trichloroethylene) against relevant EU legislation. Despite there being at least three different EU acts dealing with risk assessment, classification, and marketing of substances such as the one in question, none actually precluded the prohibition of industrial use of trichloroethylene by a Member State.^{[1] [2] [3] [4] [5] [6] [7]} In another case the Court concluded that in the absence of provisions to the contrary, restrictions on the marketing and use in the Member States of certain listed substances and preparations did not apply to products treated with such substances or preparations.8¹ However, in Nordiska Dental the Court ofJustice rejected the contention that Directive 93/42/EEC82 concerning medical devices did not preclude a prohibition on exportation of dental amalgams containing mercury, since the objective of the Directive related to safety and health protection with regard to the use of medical devices whereas the national measure had environmental protection at its objective.8³ This has been criticised as extending the harmonising effect of product-related regulation too far, thereby preventing the Member States from taking environmental protection measures even in cases where the EU act is not in fact concerned with protection of the environment in the wider sensed⁴

In a case concerning technical specifications for fuels the Court of Justice pointed out that the harmonisation achieved by Directive 98/70 only applies within the limits of the scope ratione materiae of that Directive^ that is, when the fuel technical specifications which that directive seeks to harmonise are at issue. Whereas the Directive deals with technical specifications on health and environmental grounds for certain fuels, the Member State concerned was not prevented from laying down quality requirements that serve to ensure the safety of such a fuel.8⁶ There is hence a need to carefully analyse what is actually regulated by a legal act and what is the purpose of that regulation.

Legal acts that harmonise requirements on products, for example qualities that affect their impact on health or the environment, often contain a so-called market clause. Such a clause typically makes explicit that the placing on the market and use of products that comply with the relevant provisions of the legal act in question may not be restricted with reference to the concerns addressed by the act. This can assist in construing the extent of the harmonising effect affected by the legal act, but the level of clarity of such clauses varies. An example of a market clause is that found in Directive 2006/66/EC on batteries and accumulators and waste batteries and accumulators, according to which

Member States shall not, on the grounds dealt with in this Directive, impede, prohibit, or restrict the placing on the market in their territory of batteries and accumulators that meet the requirements of this Directive.^[8]

Although the phrase ‘the grounds dealt with in this Directive’ may give rise to differing interpretations, this must still be considered a fairly clear definition of what is harmonised by the Directive. It does not affect the right of Member States to restrict the placing on the market of batteries on grounds not dealt with in the Directive, nor does it preclude restrictions of the use of batteries not related to their placing on the market. Directive 2006/66/EC is also interesting because it is based on two legal bases, ones corresponding to the current Articles 114 and 192 TFEU. The preamble also specifies that it is the market clause and two other articles which are based on Article 114, thereby entailing complete harmonisation, whereas the rest of the act has Article 192 as its legal basis.

A less clear market clause is found in the REACH regulation. According to its Article 128,

Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.

There is also a second paragraph according to which:

Nothing in this Regulation shall prevent Member States from maintaining or laying down national rules to protect workers, human health and the environment applying in cases where this Regulation does not harmonise the requirements on manufacture, placing on the market or use.

Here there is no reference to the grounds dealt with in the Regulation. Instead the harmonising effect seems to apply to all manufacturing, import, placing on the market, and use of substances which ‘fall within the scope’ of the Regulation, provided that these activities comply with REACH. There is, however, an explicit exemption for ‘national rules to protect workers, human health and the environment’, but this only applies in cases where the Regulation does not harmonise the requirements on manufacture, placing on the market, or use. That makes it a description of what would have applied anyway, had there not been any market clause, since a legal act based on Article 114 TFEU is harmonising but does not harmonise requirements which it does not harmonise. In the absence of the second paragraph the market clause of REACH could have given the impression that REACH, by harmonising everything within its ‘scope’, in fact harmonises issues not explicitly regulated by it. As will be further discussed in Chapter 13 on chemicals, defining the harmonising effect of REACH—a legal act of monumental proportions, subjecting different categories of chemical substances to different levels or regulation—is no easy task.

The room for action by individual Member States is also affected by the existence of various exemptions and safeguard clauses in harmonising EU acts. Market-related acts often give the Member States an explicit right to take provisional measures to deal with unforeseen risks—for example by restricting or prohibiting the use and/or sale of a product on their territories—while awaiting a decision by the Commission on how the issue should be handled at EU level.^{[9] [10]} Article 114 TFEU even requires that harmonisation measures based on that article include ‘in appropriate cases’ a safeguard clause authorising the Member States to take, for one or more of the noneconomic reasons referred to in Article 36 TFEU, provisional measures subject to an EU control procedure.

There are also examples of environmental acts, that is, those based on what is now Article 192 TFEU, which allow for Member States to go below the generally prescribed level of protection under certain circumstances.89 Another kind of clause is that which holds that the legal act in question shall not prevent the Member States from taking more stringent protective measures. Such statements are most common in the preambles of environmental acts, and then serve as a reminder of what follows from Article 193 TFEU. One example, where the statement is not in the preamble, is that found in Article 14 of the Birds Directive according to which ‘Member States may introduce stricter protective measures than those provided for under this Directive’.^{[11] [12] [13]} However, this does not mean that any Member State is free to take protective measures in respect to any kind of bird. In van den Burg a Member State was not allowed to prohibit the importation and marketing of a bird which did not naturally occur on its territory and which was neither migratory nor endangered when such bird could be hunted lawfully in accordance with both the legislation of another Member State and with the Birds Directive.9¹ There are also examples of individual Member States being granted exemptions or extended deadlines for complying with EU legal acts.92

There appears also to exist a possibility to make exceptions from EU law in order to protect a general interest which is superior to the interest which an EU act aims to protect. In Leybucht the Court of Justice accepted the carrying out of dyke works and the strengthening of coastal structures, although that reduced the extent of a special protection area and could not be justified under the provisions of the Birds Directive. The danger of flooding and the protection of the coast were found to constitute ‘sufficiently serious reasons’ as long as the measures were confined to a strict minimum and involved only the smallest possible reduction of the special protection area.^{[14] [15] [16]} The needs of fishing vessels could not, as economic interests, be taken into account as such, but since the fishing-related part of the project had at the same time specific positive consequences for the habitat of birds, a desire to ensure the survival of a fishing port could still be taken into account because of ‘offsetting ecological benefits’^⁴

The existence of a general principle of superior interests that can justify derogations from EU law when such derogations are not mandated by the legal act in question is not evident. Advocate General Kokott has, however, suggested that a similar reasoning can be applied outside the field of habitat and species protection.95 It does seem quite reasonable, not to say imperative, that there are circumstances under which the Member States are justified to derogate from EU law without explicit mandate in order to protect against serious threats to human life and health and public security. The problem is more to define which circumstances and values are grave enough. It should in any event be clear that such circumstances would have to be exceptional, the values protected truly important, and the measures taken cause as little harm to the objectives pursued by the EU act in question as possible.

• [1] Case C-473/98 Toolex Alpha ECLI:EU:C:2000:379, paras 29—32.
• [2] Case C-127/97 Burstein ECLI:EU:C:1998:456, para 24.
• [3] Council Directive 93/42/EEC concerning medical devices [1993] OJ L 169/1.
• [4] Case C-288/08 Nordiska Dental ECLI:EU:C:2009:718, para 33.
• [5] L Kramer, ‘Comment on case C-288/08 “Kemikalieinspektionen v. Nordiska Dental AB”Judgment of the Court of 19 November 2009’ (2010) 7 Journal for European Environmental &Planning Law 124—8, 127.
• [6] Directive 98/70/EC of the European Parliament and of the Council relating to the quality ofpetrol and diesel fuels and amending Council Directive 93/ 12/EEC [1998] OJ L 350/58.
• [7] 86 Case C-251/14 Balazs ECLI:EU:C:2015:687, paras 38^0.
• [8] Directive 2006/66/EC of the European Parliament and of the Council on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC [2006] OJ L 266/1, Art 6.
• [9] Directive 2001/18/EC of the European Parliament and of the Council on the deliberate releaseinto the environment of genetically modified organisms and repealing Council Directive 90/220/EEC[2001] OJ L 106/1.
• [10] See, eg, Council Directive 98/83/EC on the quality of water intended for human consumption[1998] OJ L 330/32, Art 9.
• [11] Directive 2009/ 147/EC of the European Parliament and of the Council on the conservation ofwild birds [2010] OJ L 20/7. The first version of the Birds Directive was decided before there was alegal basis for environmental protection, hence the need for including such a clause in the operativepart of the Directive.
• [12] Case C-169/89 Gourmetterie Van den Burg ECLI:EU:C:1990:227.
• [13] 92 See, eg, European Parliament and Council Directive 94/62/EC on packaging and packagingwaste [1994] OJ L365/10, Art 6 paras 7 and 11.
• [14] Case C-57/89 Commission v Germany ECLI:EU:C:1991:89 (‘Leybucht’), paras 21—23.
• [15] Ibid (n 93), paras 24—26.
• [16] See the reference to ‘absolutely overriding reasons in the public interest’ in her Opinion in Joined Cases C-165/09 to C-167/09 StichtingNatuur en Milieu and Others ECLI:EU:C:2010:775, para 115.